Efficacy and safety profile of generic IOP-lowering agents

AIM: To compare the efficacy and safety of Prolatan in terms of hypotensive effect, dynamic changes in functional tests, and adverse reactions.

METHODS: 60 patients newly diagnosed with primary open-angle glaucoma (POAG) were randomized into two groups. In group 1 (n=36), Xalatan® once daily was prescribed. In group 2 (n=38), Prolatan once daily was prescribed. IOP (IOPcc) was measured using Reichert® 7 Auto Tonometer at baseline and week 2, 6, and 12. Functional tests (i.e., mean deviation, pattern standard deviation, RNFL Thickness, Rim Area, Disc Area, Cup Volume, and Average Ganglion Cell Complex Thickness) were performed at the enrollment and by the end of week 12. Adverse reactions were reported at every step.

RESULTS: 12-week treatment with Xalatan® and Prolatan resulted in IOP lowering by 30% and 31%, respectively, as compared with baseline level (P0). Maximum hypotensive effect was observed after 6 weeks (31% and 34%, respectively). By week 12, insignificant IOP rising (by 29% and 32%, respectively) as compared with baseline level was observed. Therefore, IOP-lowering efficacy of these agents is similar. By the end of week 12, visual acuity improved in Prolatan group (p<0.05) while mean deviation and pattern standard deviation improved in both groups (p<0.05). Average RNFL Thickness improved in Xalatan® group while disc area and average Ganglion Cell Complex Thickness improved in Prolatan group. In general, other parameters improved as well, however, these changes were less significant. After 2 weeks of the treatment, 2 patients of group I and 4 patients of group II complained of ocular discomfort and mild conjunctival hyperemia. By the end of week 12, none of these adverse reactions were reported. Neither systemic adverse reactions nor treatment discontinuation were reported.

CONCLUSIONS: Prolatan is similar to original latanoprost in terms of hypotensive effect and reduces IOP in POAG by, on average, 30% as compared with baseline level. IOPlowering effect is accompanied by indirect neuroprotection illustrated by the improvement of functional tests. This agent is characterized by minor topical adverse reactions. Prolatan may be recommended for POAG to reduce IOP. 

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